Manager- Manufacturing Quality EngineerBayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches.

Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide.

Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Womens Healthcare.

As a specialty pharmaceuticals company, we at Bayer HealthCare focus our efforts where we can have the most impact.

Our Diabetes Care division is one of the largest self-test diagnostic businesses in the world, supporting customers in 100 countries.

Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals.

More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world.

Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals well all hold dear.Job description The primary responsibility of this position is to oversee the quality processes and quality engineering group that support Diabetes Care Mishawaka manufacturing, OEMs and contract manufacturers/packagers.

This position is responsible for assuring that the quality of manufacturing and release processes meets or exceeds customer expectations, including regulatory requirements.The Candidate will: Direct quality engineering activities supporting Diabetes Care Mishawaka manufacturing and contract manufactures and coordinates best practices with other Diabetes Care manufacturing sites;Optimize process control and documentation practices to simplify quality documentation while minimizing risk to product quality;Provide quality direction to key production support groups including Corrective and Preventive Action Teams (CPATs), Validation Approval Team (VAT), Process Software Configuration Control Board (CCB) and Product Supply Business Unit Managers;Interface with Supplier Management to ensure alignment with quality practices at suppliers, contract manufacturers and OEMs;Serve as the accountable quality decision maker for production issues arising from Product Supply, Marketing, R&D and QA/RA;Develop measures to monitor manufacturing quality for continuous improvement and effectiveness of root cause investigation/corrective actions;Provide professional growth opportunities for quality engineering staff;Your qualifications The selected candidate is required to possess the following: Bachelor's in the Sciences, Engineering or Life Sciences with 10 years relevant job experience;Strong Management experience;Ability to manage senior scientists and engineers with a focus on personal development in addition to technical development;Applying quality system principles to a production environment including management of nonconforming product/process, technical approval of engineering changes, implementing corrective and preventative actions (CAPA), verification/validation of product/process improvements; Working knowledge of SPC, Six-Sigma, TQM or comparable process management tools with Minitab experience desired.

Understanding of production documentation including Bills Of Materials (BOMs), Device Master Records, Device History Records production process orders;Strong computer skills including use of Microsoft Word, Excel and PowerPoint.

Database experience a plus;Previous healthcare FDA/ISO experience;Effective written and verbal communication skills;Strong interpersonal skills, including the ability to work with and influence individuals of diverse backgrounds and technical abilities;Ability to make sound quality decisions under pressure;Preferred skills: Six-Sigma Black Belt and/or ASQ CQE/CQM certification preferred;Experience with SAP preferred;Previous medical devices;Strong background in process/equipment/facility validation preferred;Masters degree.

Your application We offer a wide variety of competitive compensation and benefit programs.

In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment.

We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home.

You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences.

We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now. https://mybayerjob.

bayerbbs.com/sap(bD1lbiZjPTAwNSZwPTM0NDU3)/bc/bsp/sap/hrrcf_pinstappl/application.do?PARAM=UElOU1RfR1VJRD00QUZFODc5QTU4RTQwMTg3RTEwMDgwMDAwQUJGRDkwRQ%3d%3d&rcfcontext=APP_US To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

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